(149 days)
No
The device description details a qualitative immunoassay based on antibody binding and color band formation, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is described as a diagnostic assay for detecting the presence of human hemoglobin in fecal specimens, which helps in identifying gastrointestinal diseases, rather than providing therapy or treatment.
Yes.
The device qualitatively detects human hemoglobin in fecal specimens, which can be indicative of gastrointestinal diseases, classifying it as a diagnostic device.
No
The device description clearly outlines a physical immunoassay test card that uses chemical reactions and visual interpretation of color bands to detect hemoglobin. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of intact hHb (human hemoglobin) in fecal specimens." This is a test performed on a sample taken from the human body to provide information about a physiological state.
- Device Description: The description details a "qualitative, sandwich colloidal gold conjugate immunoassay" that uses antibodies to detect a specific substance (human hemoglobin) in a biological sample (feces). This is a typical description of an in vitro diagnostic test.
- Sample Type: The test is performed on "fecal specimens," which are biological samples taken from the body.
- Purpose: The purpose is to detect "human fecal occult blood, which may be indicative of gastrointestinal disease." This is providing diagnostic information.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, and tissues, taken from the human body, to detect diseases, conditions, or infections. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be in dicative of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is an immunological test for both professional and over the counter use.
Product codes
KHE
Device Description
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a qualitative, sandwich colloidal gold conjugate immunoassay for the determination of human hemoglobin in feces. The method employs a unique combination of monoclonal antibodies to selectively identify hemoglobin in test sample with a high degree of sensitivity. In less than 5 minutes, elevated levels of human hemoglobin as low as 50 ng/ml can be detected, and positive results for high levels of hemoglobin can be seen in the test as early as two to three minutes. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to another anti-hemoglobin antibody in the positive reaction zone and produces a pink-ross color band when hemoglobin concentration is greater than 50 ng/ml. In the absence of hemoglobin, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative control zone. Unbind conjugate binds to the reagents in the negative control zone, producing a pink rose color band, demonstrating that the reagents and device are functioning correctly.
A NEGATIVE specimen produces one distinct color bands in control area. A POSITIVE specimen produces two color band in the control and test area. There is no meaning attributed to color or its intensity for either line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and over the counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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K063693
MAY 11 2007
510(k) Submission For Forsure One Step Fecal Occult Blood (FOB) Screen Card Test New Bay Bioresearch Co., Ltd.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: Designed (k) Number to be Determined
Submitter:
Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516
Contact Person:
Rodrigo Berlie New Product Development Director Telephone: (760) 828-0990 Facsimile: (760) 602-2999
Preparation Date:
December 08, 2006
Device Information:
Trade or Proprietary Name: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test
Common/Usual Name: Lateral flow immunochromatographic assay for detection of human hemoglobin or fecal occult blood in feces
Device Classification Name: Immunoassay of human hemoglobin or fecal occult blood
Regulatory Name: Human Hemoglobin or Fecal Occult Blood (FOB) Test System
Regulation Section: 21 CFR § 866. 6550
Regulatory Class: Class II
Product Code: KHE
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Panel: Hematology (81)
Predicate Devices:
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is substantially equivalent to WHPM Hemosure One Step Fecal Occult Blood (FOB) Test cleared by FDA (K041202) for its stated intended use.
Device Description:
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a qualitative, sandwich colloidal gold conjugate immunoassay for the determination of human hemoglobin in feces. The method employs a unique combination of monoclonal antibodies to selectively identify hemoglobin in test sample with a high degree of sensitivity. In less than 5 minutes, elevated levels of human hemoglobin as low as 50 ng/ml can be detected, and positive results for high levels of hemoglobin can be seen in the test as early as two to three minutes. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to another anti-hemoglobin antibody in the positive reaction zone and produces a pink-ross color band when hemoglobin concentration is greater than 50 ng/ml. In the absence of hemoglobin, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative control zone. Unbind conjugate binds to the reagents in the negative control zone, producing a pink rose color band, demonstrating that the reagents and device are functioning correctly.
A NEGATIVE specimen produces one distinct color bands in control area. A POSITIVE specimen produces two color band in the control and test area. There is no meaning attributed to color or its intensity for either line.
Intended Use:
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be in dicative of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.
Comparison to Predicate Device(s):
Both devices (Forsure and WHPM) are for the qualitative determination of the Fecal Occult Blood. The specific antibodies against human hemoglobin were used in both devices. All test devices are visually -read single use device. The cutoff of each analyte is same (50 ng/ml or 50 ug/g of feces).
2
Summary:
The information provided in this pre-market notification demonstrates that Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is substantially equivalent to WHPM Hemosure One Step Fecal Occult Blood (FOB) Test. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is safe and effective for its stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
New Bay Bioresearch Company, Limited C/O Aventir Biotech, LLC 3108 Avenida Olmeda Carlsbad, California 92009 ATTN: Rodrigo Berlie
MAY I 1 2007
Re: K063693
Trade/Device Name: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: December 11, 2006 Received: December 14, 2006
Dear Mr. Berlie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
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Page 2 - Rodrigo Berlie
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker, Jr., M.D., Ph.D.
Robert L. Becker, Jr., M.D Director Division of Immunology and Hematology
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device name: Forsure One Step Fecal Occult Blood (FOB) Screen Card Test
Indications for Use:
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be in dicative of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is an immunological test for both professional and over the counter use.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use 7 (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robe R. Rote/
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K063693
CONFIDENTIAL